BIFEN SUSPENSION 100MG5ML

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Prenos Navodilo za uporabo (PIL)
06-12-2021
Prenos Lastnosti izdelka (SPC)
08-12-2021

Aktivna sestavina:

IBUPROFEN

Dostopno od:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

IBUPROFEN

Enote v paketu:

100 ml

Izdeluje:

PT Actavis Indonesia

Navodilo za uporabo

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BIFEN SUSPENSION
Ibuprofen (100mg/5ml)
1
WHAT IS IN THIS LEAFLET
1.
What Bifen Suspension is
used for
2.
How
Bifen
Suspension
works
3.
Before
you
use
Bifen
Suspension
4.
How
to
use
Bifen
Suspension
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Bifen Suspension
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
BIFEN
SUSPENSION
IS
USED FOR
It can be used for:
- Children: Symptomatic relief
of
pain
and
fever
associated
with colds, influenza, toothache,
bronchitis (inflammation of the
airway) and other bacterial and
viral infections.
- Adults: Management of mild
to moderate pain in conditions
such as dysmenorrhoea (period
pain), migraine, after operation
pain,
ankylosing
spondylitis
(chronic
inflammatory
disease
of
the
skeleton),
osteoarthritis
(degenerative joint disease), and
rheumatoid
arthritis
(systemic
inflammatory
disorder
that
affects
joints)
and
in
other
musculoskeletal
and
joint
disorders.
HOW BIFEN SUSPENSION WORKS
This
medicine
contains
Ibuprofen
which
belongs
to
a
group of medicines called non-
steroidal
anti-inflammatory
drugs
(NSAIDs)
which
act
to
relieve
pain,
swelling
(inflammation)
and
reduce
fever.
BEFORE
YOU
USE
BIFEN
SUSPENSION
_- When you must not take it _
Do not take Bifen Suspension
if:
-If you have active stomach and
intestinal bleeding.
-If you have had asthma, rhinitis
(Inflammation
of
the
nasal
mucous
membrane),
urticaria
(itching
or
hives)
or
the
symptoms
become
worsen
caused by Aspirin or NSAIDs.
-If you are allergic to ibuprofen
or any other ingredients in the
product,
aspirin
or
other
non-
steroidal
anti-inflammatory
medicines
_- Before you start to take it _
Always take Bifen Suspension
exactly
as
your
doctor
or
Pharmacist
has told
you. You
should check with your doctor
or pharmacist if:
•
you are allergic to any other
medicines
•
you are allergic to any other
orally consumed substances
-you have bleeding disorder
-you
have
heart
problem
or
stroke
-you
have
kidn
                                
                                Preberite celoten dokument
                                
                            

Lastnosti izdelka

                                DESCRIPTION:
Orange suspension with orange
flavour and sweet taste.
COMPOSITION:
Ibuprofen BP 100 mg / 5ml
PHARMACOLOGY:
Ibuprofen is a non-steroidal anti-
inflammatory that possesses
analgesic and anti-pyretic
activities. It inhibits the activity
of the enzyme cyclo-oxygenase,
resulting in decreased formation
of precursors of prostaglandins
and thromboxanes from
arachidonic acid.
PHARMACOKINETIC:
Approximately 80% of an oral
dose of ibuprofen is absorbed
from the GI tract. About 90-99%
of a dose is bound to plasma
proteins. The plasma half-life of
the drug has been reported to be
2-4 hours. Excretion of ibuprofen
is essentially completed within
24 hours.
INDICATION:
Children : Symptomatic relief of
pain and fever associated with
colds, influenza, toothache,
bronchitis and other bacterial and
viral infections.
Adults : Management of mild to
moderate pain in conditions such
as dysmenorrhoea, migraine,
postoperative pain, ankylosing
spondylitis, osteoarthritis and
rheumatoid arthritis and in
other musculoskeletal and joint
disorders.
ADVERSE EFFECT:
Gastrointestinal disturbances,
peptic ulceration, gastrointestinal
bleeding. Others include
headache, dizziness,
nervousness, skin rash, pruritus,
tinnitus, edema, depression,
drowsiness, insomnia, blurred
vision, hypersensitivity,
impairment of renal function and
thrombocytopenia.
PRECAUTIONS:
Ibuprofen should be given with
care to patient with asthma or
bronchospasm, bleeding disorders,
cardiovascular disease, a history
of peptic ulceration and in liver
and renal failure. Care is required
in those who are receiving
coumarin anticoagulants.
Ibuprofen should be discontinued
in patients who experience
blurred or diminished vision or
changes in colour vision. Patients
with collagen disease may be
at increased risk of developing
aseptic meningitis.
WARNING:
RISK OF ULCERATION, BLEEDING
AND PERFORATION WITH NSAID
Serious GI toxicity such as
bleeding, ulceration and
perforation can occur at any
time, with or without warning
symptoms in patients treated
with NSAID therapy. Al
                                
                                Preberite celoten dokument
                                
                            

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